Determination of paclitaxel and related taxanes in bulk drug and injectable dosage forms by reversed phase liquid chromatography

Analytical Chemistry
L K Shao, David C Locke

Abstract

Baseline separation of 15 taxanes including paclitaxel (Taxol) was achieved on pentafluorophenyl (PFP) HPLC columns. Methods using aqueous acetonitrile gradients on each of two commercial PFP columns were developed that are suitable for the determination of potency, content uniformity, and degradation profile of the paclitaxel bulk drug and injectable dosage form. The elution order is apparently related to molecular size, the number of acetylated hydroxyl groups, and the substitution of a xylosyl group at the 7-position. The resolution of several of the taxanes is a sensitive function of the starting eluent composition and the programming rate, which requires optimization of the methods on both columns. Retention of 10 of the taxanes was studied over the temperature range from 30 to 70 degrees C, and enthalpies of transfer, delta H degree, were determined. Conversion of a hydroxy group to an acetyl group, which can interact more strongly with the fluorines on the PFP, has a large effect on the delta H degree, as does the addition of a xylosyl derivative to the 7-hydroxy. The methods developed for the injectable drug form allow good resolution of the taxanes from the excipient Cremophor EL, a polyethoxylated castor oil used with...Continue Reading

References

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Citations

Aug 10, 2000·Analytical Biochemistry·S H SheikhA Mulchandani
May 7, 2004·Journal of Pharmaceutical and Biomedical Analysis·Irinel BadeaAurel Tudose
May 7, 2004·Journal of Pharmaceutical and Biomedical Analysis·Dana CiutaruAurel Tudose
Oct 6, 2011·Chemical Reviews·Yu-Fang WangBin Cong
Dec 29, 2004·Journal of Asian Natural Products Research·Yi JiangJian-Min Chen
Jan 10, 2003·Applied Occupational and Environmental Hygiene·Rodney R LarsonH Kenneth Dillon
Jan 11, 2014·Bioorganic & Medicinal Chemistry Letters·Caihong LiZhiyi Yao
Dec 6, 2005·Journal of Pharmaceutical and Biomedical Analysis·James D PerdueDaniel R DeVido
Oct 18, 2019·Critical Reviews in Food Science and Nutrition·Supradip SahaKaushik Banerjee
Dec 15, 2017·Critical Reviews in Analytical Chemistry·Renata Carolina AlvesMarlus Chorilli

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